USER GUIDE - GN ReSound

The scientific concepts that form the basis for the deviceThe TSG module provides sound enrichment with the aim of surrounding the tinnitus sound with a neutralsound which is easily ignored. Sound enrichment is an important component of most approaches to tinnitusmanagement, such as Tinnitus Retraining Therapy (TRT). To assist habituation to tinnitus, this needsto be audible. The ideal level of the TSG module, therefore, should be set so that it starts to blend with thetinnitus, and so that you can hear both your tinnitus as well as the sound used.In a majority of instances, the TSG Module can also be set to mask the tinnitus sound, so to provide temporaryrelief by introducing a more pleasant and controllable sound source.Significant physical characteristicsAudio signal technologyDigitalAvailable soundsWhite noise signal which can be shaped with the following configurations:High-pass filter Low-pass filter500 Hz 2000 Hz750 Hz 3000 Hz1000 Hz 4000 Hz1500 Hz 5000 Hz2000 Hz 6000 HzThe white noise signal can be modulated in amplitude with an attenuation depth of up to 14dB.Prescription use of this TSG hearing instrumentThe TSG module should be used as prescribed by your doctor, audiologist or hearing healthcare professional.In order to avoid permanent hearing damages, the maximum daily usage depends on the level ofthe generated sound.Should you develop any side effects from using the sound generator, such as dizziness, nausea, headaches,perceived decrease in auditory function or increase in tinnitus perception, you should discontinueuse of sound generator and seek medical evaluation.The target population is primarily the adult population over 18 years of age. This product may also be usedwith children 5 years of age or older. However, children and physically or mentally challenged users will requiretraining by a doctor, audiologist, hearing healthcare professional or the guardian for the insertion andremoval of the hearing instrument containing the TSG module.Important notice for prospective sound generator usersA tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth tomask internal noises. It is also used as an aid in hearing external noises and speech.Good health practice requires that a person with a tinnitus condition have a medical evaluation by a licensedphysician (preferably a physician who specializes in diseases of the ear) before using a sound generator.Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologistsor otorhinolaryngologists.The purpose of medical evaluation is to assure that all medically treatable conditions that may affect tinnitusare identified and treated before the sound generator instrument is used.36 37